ADVENTRX Presents Data at the 2008 American Association for Cancer Research
SAN DIEGO, April 15 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) announced that it presented pharmacokinetic data from its registrational bioequivalence clinical study of ANX-530 (vinorelbine emulsion) at the 2008 American Association for Cancer Research (AACR) Annual Meeting. The poster presentation, entitled "Pharmacokinetic equivalence observed between an emulsion formulation of vinorelbine (ANX-530) and vinorelbine solution in a clinical study of patients with advanced cancer," was presented by Joachim P.H. Schupp, M.D., Vice President of Medical Affairs, on April 13.
"ANX-530 is a near term value-driver for ADVENTRX and we are excited to have met the primary endpoint in this registrational trial," stated Evan M. Levine, Chief Executive Officer and President of ADVENTRX. "We are preparing our New Drug Application (NDA) for ANX-530, which we anticipate submitting before the end of this year. ANX-530 could be our first commercially available oncology product and, if approved by the FDA within its 10 month review goal, may generate revenues for the company towards the end of 2009."
The bioequivalence study of ANX-530 was a crossover comparison of ANX-530 and Navelbine with a primary objective of demonstrating the pharmacokinetic equivalence of ANX-530 and Navelbine. Determining the safety of a single dose of ANX-530 was a secondary objective. In the first week, patients were dosed with either ANX-530 or Navelbine, and after a washout period, were dosed with the opposite drug during the second week of treatment.
Pharmacokinetic equivalence was demonstrated by a statistic
|SOURCE ADVENTRX Pharmaceuticals, Inc.|
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